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Not yet recruiting NCT07516561

Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

Phase III Interventional Alopecia, Androgenetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APSMNF 1, APSMNF 2, Eniagor®.
Who it may be relevant to
Registry conditions: Alopecia, Androgenetic. Basic parameters: 18 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Phase III Randomized, Multicenter, Double-blind, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

Overview

The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.

Interventions

  • Drug APSMNF 1
    Administer twice a day during 24 weeks.
  • Drug APSMNF 2
    Administer twice a day during 24 weeks.
  • Drug Eniagor®
    Administer twice a day during 24 weeks.

Primary outcome measures

  • Variation in hair density assessed by phototrichogram. [Time frame: Change from baseline after 24 weeks of treatment.]
Secondary outcome measures (1)
  • Adverse events incidence and classification [Time frame: Through study completion, up to 24 weeks]

Eligibility criteria

Inclusion criteria

  • Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ;
  • Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period.

Exclusion criteria

  • History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation;
  • Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
  • Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening;
  • Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Clinica Geral Investiga Ltda — Campinas

Identifiers

NCT: NCT07516561 · APS001/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗